Weight Loss Pilot Study in Postmenopausal Breast Cancer Survivors

August 1, 2018 updated by: USDA Grand Forks Human Nutrition Research Center
The primary objective of this pilot study is to determine the effect of weight loss on a wide range of biomarkers associated with risk of breast cancer recurrence in overweight and obese breast cancer survivors. We hypothesized that weight loss would result in a statistically significant improvement in biomarkers associated with risk of breast cancer recurrence.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Women who are overweight, obese or gain weight after a breast cancer diagnosis are at greater risk for recurrence and death compared with lighter women. There have been a few studies examining the effects of different interventions on weight loss in breast cancer survivors but very few have examined the effect of weight loss interventions on circulating levels of markers associated with cancer risk. The overall objective of this proposal is to determine how weight loss affects circulating levels of biomarkers associated with breast cancer risk and recurrence, and quality of life of overweight and obese breast cancer survivors. The central hypothesis is that weight loss will decrease the levels of markers adversely associated with breast cancer and increase quality of life in these women. To test the central hypothesis the following specific aims will be pursued:

  • To assess the effects of two different weight loss interventions on biomarkers associated with breast cancer risk and recurrence
  • To assess the impact of the weight loss interventions on quality of life and sleep
  • To assess the impact of weight loss on measures of bone health

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

44 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • postmenopausal (defined as experiencing at least 12 months without a menstrual period)
  • diagnosed with operable invasive breast cancer and treated with mastectomy or with lumpectomy and radiation
  • completed all surgery, radiation, and systemic chemotherapy one to 12 months prior to enrollment
  • BMI ≥ 27 kg/m2
  • less than 7 servings of alcohol per week
  • willing to be randomized into either group
  • not planning to move away from the area during the period of study
  • non-smoker

Exclusion Criteria:

  • serious illness requiring medical treatment
  • inability to participate in physical activity due to severe disability
  • history of schizophrenia, psychosis or untreated major depression
  • unwilling to commute to study site once per week
  • failure to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calorie restricted diet plus exercise
See Intervention Description
Other: Calorie restricted diet plus exercise
Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
Active Comparator: Weight management classes
See Intervention Description
Other: Weight management classes
Weekly 1-hour weight management classes for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in body weight
Time Frame: 0, 6, 12, 18 weeks
0, 6, 12, 18 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

USDA Grand Forks Human Nutrition Research Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Susan Raatz, PhD, MPH, RD, USDA Grand Forks Human Nutrition Research Center
  • Principal Investigator: Mindy S Kurzer, PhD, MPH, RD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

August 1, 2010

Study Registration Dates

First Submitted

October 18, 2016

First Submitted That Met QC Criteria

October 18, 2016

First Posted (Estimate)

October 21, 2016

Study Record Updates

Last Update Posted (Actual)

August 3, 2018

Last Update Submitted That Met QC Criteria

August 1, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UMN999
  • U54CA116849 (U.S. NIH Grant/Contract)
  • CPRC#2008NTLS107 (Other Identifier: University of Minnesota Cancer Protocol Review Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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